Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Feb 2007
[Participation to international registration trials--from the investigator's standpoint].
Clinical developments of new anti-cancer drugs in Japan are far behind from the Western as well as Asian countries, which resulted in much delay for indicating them into Japanese patients. The causes of delay are considered to exist in regulatory authorities, pharmaceutical companies, and investigators, respectively. ⋯ A Japan-Korea joint phase I study of new agent for gastric cancer is also now being conducted. It is time for Japanese GI investigators to recover the delay in new drug development and to make an effort for new evidence originated from Japan.
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Clinical trial environment in Japan has issues such as high clinical development cost, resource-intensive and time-consuming preparation for clinical trial conduct in each clinical site, long "White Space" and slow speed in pt.recruitment. As a result of the Guideline revision in Nov., 2005, overseas' Phase III data is now usable as pivotal data for NDA submissions. ⋯ It is proposed that Japan take initiative to set up the network such as "Asian Clinical Trial Group" and collaborate with other Asian countries from the beginning of early stage development. Eventually, Asia should become the third region to create clinical evidence, same as to EU and the US.
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Gan To Kagaku Ryoho · Feb 2007
[Participation in the international multi-countries study-operational issues from company view point].
AstraZeneca KK has participated in 6 international clinical studies in the development of anticancer agents. Having learned from the experiences, we would like to present operational issues of conducting the international studies in the development of anticancer agents from the standpoint of a pharmaceutical company. Also,we would like to show you differences in Japan from Western and other Asian countries, some aspects that we have to improve or make more efforts, and proposals for the future development to provide patients with good products simultaneously worldwide.
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Gan To Kagaku Ryoho · Feb 2007
[Participation in the global study. Activities and issues from the bedside].
Global study is becoming popular in the field of the anti-cancer drug development in Japan as well as in the US and European countries. There are many issues to be solved around the bedside and equipping the infrastructure is most important. Early drug development is also important,and we are maintaining the quality and speed in the phase I studies.
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Gan To Kagaku Ryoho · Feb 2007
[Operational aspect of participation in the multi-national clinical trials from the foreign pharmaceutical company's standpoint].
As a means to reduce the delay with the West, the enhanced use of multi-national clinical trials is expected. It is necessary to improve the presence of Japan as a development base by making the best use of the quality of the clinical trials and becoming more competitive in terms of the speed and the cost as compared with other Asian countries. ⋯ The elimination of the difference between the domestic and international regulations is expected of the regulator. Finally, the revision of medical institutions by the government would contribute improvements in the current situation where staff are too busy to conduct clinical trials.